MONTREAL, Nov. 17 /PRNewswire/ - Aegera Therapeutics Inc. is pleased to announce preliminary results of their first Phase I human clinical trial for Aegera’s proprietary second generation XIAP antisense therapeutic, AEG35156. The study’s objectives were to establish the maximum tolerated dose of AEG35156 given as a 7-day continuous infusion every 3 weeks, determine the pharmacokinetic profile of AEG35156, evaluate XIAP inhibition in peripheral blood mononuclear cells and, where feasible, in tumor cells, and document anti-tumor activity.
Study results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia, by Dr. Malcolm Ranson, Principal Investigator of the Cancer Research-UK sponsored study and Director of the Derek Crowther Trials Unit at the Christie Hospital in Manchester, UK. The trial is also being conducted at the Cancer Research UK Oncology Unit, within the University of Edinburgh Cancer Research Centre, by Dr. Duncan Jodrell.
“The toxicology profile of AEG35156 has fallen within the familiar, class-related antisense side effects of thrombocytopenia and elevated transaminases,” commented Dr. Malcolm Ranson, “We have also seen signs of anti-tumour activity associated with decreases in XIAP mRNA in peripheral blood leucocytes, as well as marked transient decreases in peripheral lymphoblasts in one patient, with significant and pronounced XIAP mRNA knockdown.”
“We are very pleased that our first monotherapy study shows preliminary evidence of XIAP mRNA knockdown and suggestive evidence of anti-tumor activity,” added Dr. Jacques Jolivet, VP Clinical at Aegera Therapeutics, “These initial results further support our on-going evaluation of AEG35156 in two additional trials in combination with docetaxel for solid tumours and in combination with idarubicin/araC in AML.”
These early clinical results are also supportive of Aegera’s small molecule approach to XIAP inhibition which was recently presented at the Advances In Structure-Based Drug Discovery meeting in Philadelphia. Data was presented on a representative potent XIAP binding compound developed at Aegera. The compound modulated XIAP protein at picomolar concentrations in cancer cells and increased the apoptotic sensitization in cancer cells without affecting normal fibroblast cells.
About AEG35156
AEG35156 is now being studied in Europe, the United States, and Canada in three distinct clinical studies. AEG35156 is an inhibitor of the X-linked Inhibitor of Apoptosis Protein (XIAP), a protein that is proprietary to Aegera. XIAP is a pivotal inhibitor of apoptosis induced by both intrinsic and extrinsic death cues. Most cancer cell lines over-express XIAP, and high levels of XIAP are strongly correlated with poor prognosis in multiple cancers and leukemias. AEG35156 is a second generation XIAP antisense drug with potent anti-tumour activity in multiple in vivo animal cancer models, particularly when combined with traditional cancer therapies. The combination of AEG35156 with chemotherapeutic agents such as docetaxel represents a potential breakthrough approach to combating resistant cancers.
About Aegera
Aegera Therapeutics Inc. (“Aegera”) is a clinical stage biotechnology company uniquely focused on developing drugs to control apoptosis: inducing apoptosis to kill cancer cells and preventing apoptosis to save injured neuronal cells. AEG35156 is currently in human clinical trials as a mono-therapy and as combination therapy in solid tumors and leukemia. Aegera’s second product, AEG33783, is a broad-based neuroprotective agent in late preclinical development with proven efficacy in reversing peripheral neuropathies in animal models arising from chemotherapy and induced diabetes.
For more information, please visit Aegera’s website at www.aegera.com.
AEGERA THERAPEUTICS INC.
CONTACT: Aegera Therapeutics Inc.: Catherine So, Manager, BusinessDevelopment, (514) 288-4091, ext. 225, catherine.so@aegera.com
